In this position, you are responsible for following the Document control process
Activities related to SAP processing, role mapping, formatting, reference checks etc...
Monthly review of SOPs to ensure compliance and updates
Providing part numbers, SOP numbers, or validation numbers upon request
Communicating changes related to Quality Records (QR) and General Documents (GD)
Managing periodic reviews and status updates for Environmental Health and Safety (EHS) documents and meeting minutes
Additional Expectations
In this position, you are also responsible for
Review the R-Reviews ( Phase exit milestones )
Establish and monitor appropriate Project quality plans, targets / Objectives and methods based on laid down standards, advise the project leader on project specific adaptations
Quality Management and process controlling (key activities include monitoring and checking to make sure that the agreed key processes have been complied with)
Tracking, analyzing, and performing Root Cause analysis
Competencies
Practical knowledge of Good Documentation Practices (GDP) and SAP for upload, download and document control work.
Knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.)
Knowledge on Software Development Life Cycle and Process Lifecycle Management.
Ensuring compliance of products as per MI PLM and SHPL QMS requirements
Co-ordination with Quality Manager on various SHPL QMS related activities
Conducting/participating in Internal Audits and External Audits,
Coordination and ensuring closure of audit findings within the projects.
Process Management
Supporting for maintaining and improving of product and process quality
Skills to Collaborate with all stakeholders to implement lean /agile initiatives across organization
Quantitative Project Management using statistical methods
Desired Qualification and Experience
Qualification : BE / B.Tech/ MCA
Experience:
4 to 6 years' experience in Quality Assurance & Document control.
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